Clearance Summary
DEGANIA SILICONE INDENTI LOOPS received FDA 510(k) clearance under submission number K964547, sponsored by Degania Silicone , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-01-08.
- Submission: K964547
- Applicant / Sponsor: Degania Silicone , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 1997-01-08
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.